Spinal device leader Medtronic Inc. (NYSE:MDT) has received Food and Drug Administration approval to use its CD Horizon vertebral bone screw system to treat scoliosis that develops during adolescence.
It’s the first clearance by the FDA under its new category for pediatric adolescent idiopathic scoliosis (AIS) patients who are treated with posterior pedicle screw instruments, Medtronic said in a written statement.
The clearance also may help the Minnesota medical device giant revive its struggling spine business in Memphis, Tennessee, which is near the end of a three-year overhaul just as insurers take a harder look at whether surgery is the most cost-effective way to treat back pain, according to a Reuters analysis.
“This is a major milestone for surgeons and their pediatric patients,” said Doug King, general manager of Medtronic’s Spine business, in the statement. “With this clearance, we will now be able to provide training and education to surgeons to treat children diagnosed with AIS.”
Adolescent idiopathic (unknown cause) scoliosis is the most common type of abnormal spine curvature in children and affects nearly one million children in the United States alone, Medtronic said. AIS occurs between 10 years of age and adulthood.
Pedicle screws often are used to affix rods to the spine to correct deformities like scoliosis.
“Using pedicle screws in the treatment of adolescent idiopathic scoliosis gives my patients the best chance of correcting their spine and chest deformity, and preventing future surgeries,” said Dr. David L. Skaggs, professor and chief of Orthopaedic Surgery at Children’s Hospital in Los Angeles, Caliornia, in the Medtronic statement.
Pedicle screws also can enable children to get back to their active lives and may reduce the need for additional surgeries (and additional cost), Skaggs said.
“The opportunity to further research and study this patient population will allow us to move forward with our commitment and investment in pediatric innovation,” King said.